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This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

Condition or disease

Intervention/treatment

Vasculogenic Erectile Dysfunction

Device: Shockwave systemDevice: Sham treatment

Detailed Description:

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.

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Ages Eligible for Study:

20 Years to 80 Years (Adult, Senior)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Good general health

Vasculogenic ED for at least 6 months

International Index of Erectile Function 6 (IIEF-EF) between 11 to 25

Positive response to PDE5-I (able to penetrate on demand, Responders)

Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)